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6 Anesthesia
105
Costs
Ideally inguinal hernia repair should be performed using a
simple and safe technique that is acceptable for the patient
and easily mastered by the surgeon. The technique should
carry a low morbidity risk and also be cost-effective. The
latter aspect, cost-effectiveness, has so far attracted only
slight attention, but scrutiny to ensure that limited healthcare resources are used rationally is of the utmost
importance.
Cost comparisons for the anesthetic alternatives have
given similar results. LA provides cost advantage over both
RA and GA, regarding both total intraoperative and postoperative costs [22, 97–100]. Of three randomized controlled
trials [22, 88, 100], two found local to be cheaper than both
GA and RA [22, 100], while one observed no major difference between LA and GA [88]. The probable explanation is
that in the latter trial (O’Dwyer), all operations were performed on an in-patient basis with a mean hospital stay of
3 days. In day-case surgery, prolonged hospital stay after
groin hernia surgery is often due to the effects of anesthesia.
It follows that for cost-saving purposes, the avoidance of
such side effects is of crucial importance. Shorter total theater time, earlier discharge, and to some extent, anesthetic
equipment requirements were the main factors for the great
difference in total costs.
Conclusions
Either general, regional, or local anesthesia is suitable for
open groin hernia repair. The available scientific data sup-
port the use of local anesthesia. A great majority of ran-
domized studies comparing the anesthetic techniques
bear witness to advantage for local anesthetic such as less
postoperative pain, less anesthesia-related complaints,
less micturition difficulties, faster discharge, faster short-
term recovery, and fewer costs. However, when surgeons
inexperienced in its use administer local anesthesia, more
hernia recurrences might result.
The knowledge of the benefits of LA has not been
translated into general practice. There seems to be a discrepancy between existing scientific data and clinical
practice. This may be due, in part, to patient preferences
to undergo GA rather than either RA or LA.
The development of new short-acting intravenous general anesthetics (propofol, remifentanil) may be a valid
alternative to local infiltration anesthesia alone, as the former can be combined with intraoperative local infiltration
anesthesia for early postoperative pain relief.
Regional anesthesia especially when using high dose
and/or long-acting agents seems to have no documented
benefits in open inguinal hernia repair and increases the
risk of urinary retention, prolonged recovery, and delayed
discharge.
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6 Anesthesia
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Prostheses and Products for Hernioplasty
Karl A. LeBlanc
7
Introduction
The use of prosthetic biomaterials in the repair of hernias
of the abdominal wall is now very commonplace throughout the world. In the USA over 95% of all inguinal and
ventral hernias are repaired with a prosthetic material or
device and some countries are also beginning to approach
this figure. In other parts of the world, this is not the case.
Limitations on the use of these products include a natural
reluctance to place a biomaterial into a primary hernia or
the cost of these products. Increasing usage of these products has increased due to the fact that recurrence rates are
markedly decreased with their use (this is described in
other chapters in this text).
Incisional hernias will develop in at least 13% and perhaps as many as 20% of laparotomy incisions. The risk of
herniation is increased by fivefold if a postoperative wound
infection occurs. Other factors that predispose to the development of a fascial defect include smoking, obesity, poor
nutritional status, steroid usage, etc. While some of these
may be avoided, those patients that are found to have such a
hernia can present difficult management problems due to
the high potential for recurrence. It has been known for
many years that without the use of a prosthetic material, the
recurrence rate for ventral hernia repair is as high as 51%
[1]. The use of a synthetic material will reduce this rate to
10–24% [2]. While these publications are older, they are
still relevant in today’s management of hernia repair. Recent
data still reveals a recurrence rate of 17.1% without the use
of mesh, 12.3% with open mesh repair and 10.6% with laparoscopic mesh repair [3].
The laparoscopic repair of incisional and ventral hernias was
first performed in 1991 using the Soft Tissue Patch made by
K.A. LeBlanc, MD, MBA, FACS
Department of Surgery, Louisiana State University Health Sciences
Center, Baton Rouge, LA, USA
Minimally Invasive Surgery Institute, Baton Rouge, LA, USA
e-mail: docmba2@yahoo.com
W.L. Gore and Associates (Elkhart, DE, USA) [4]. The recurrence rate that has been reported in other recent literature varies
from 0–11% but averages approximately 5.5%. The “ideal”
prosthetic product has yet to be found. The hernia that is being
repaired and the status of the patient into which this material
will be placed should dictate the type of material that will be
chosen. This chapter will identify these goals and the properties
of the various biomaterials that are on the market today.
There are several hundred different products that can be
used in the repair of inguinal, ventral, incisional and other
hernias of the abdominal wall. In many of the products listed
below there is a paucity of published literature that verifies
the claims that are made by the manufacturers. It is very difficult to find Level 1 studies that evaluate the success or failure of the respective materials. While this is the situation at
the time of the production of this textbook, the reader is
advised to reference the available journals to identify the
uses and results of these materials. Much of the information
discussed was obtained from the respective manufacturer
directly but not in all cases. Therefore, the reader should reference the particular manufacturer for in-depth information
that cannot be provided in this text.
Indications for Use of Prosthetic Materials
Surgeons recognize that the main purpose in the use of these
materials will be the repair of a fascial defect in the abdominal wall. The main indications of use of the materials are
listed in Table 7.1.
Musculofascial tissue strength can be lost in a variety of
ways. The most common, of course, would be due to the
external etiology of the weakness that develops after a laparotomy or other abdominal incision that is larger than that
of the 5 mm laparoscopic trocar (although even this small
incision can rarely develop a hernia). Another example
would be the loss of tissue with trauma such as gunshot
wounds and/or treatment with an open abdomen. The
increase of intra- abdominal pressure that results from sig-
© Springer International Publishing AG, part of Springer Nature 2018
K.A. LeBlanc et al. (eds.), Management of Abdominal Hernias, https://doi.org/10.1007/978-3-319-63251-3_7
109
110
K.A. LeBlanc
Table 7.1 Indications for prostheses
Replacement of lost musculofascial tissue caused by:
Trauma
External
Internal
Infection
Reinforcement of native tissue weakness
Aging (laxity of tissues)
Neurological deficit (denervation)
nificant weight gain will result in an internal source of
weakening of the abdominal wall musculature. Poor nutrition and/or protein malnutrition are also sources of such
problems. Other pre-disposing factors such as emphysema
or the chronic bronchitis of individuals that smoke tobacco
products result in a constant increase in intra-abdominal
pressure because of a frequent cough. Life-threatening
infections such as fasciitis and gangrene will produce large
areas of necrosis and resultant tissue loss. More frequently,
the development of a postoperative wound infection will
increase the risk of herniation by as much as five times. In
fact, almost 30% of patients that develop a postoperative
incisional wound infection will eventually develop an incisional hernia [5]. Modern needs of patients have resulted in
the development of products that are not permanent such as
biologic meshes or synthetic products that resorb over
varying lengths of time.
The effects of aging and the declining ability of the elderly
patients to repair the native tissues will lead to the loss of fascial
integrity. This is commonly seen with the direct inguinal hernia. It also occurs with the enlargement of the linea alba that is
referred to as diastasis recti. These latter defects can enlarge
and occasionally become symptomatic, requiring repair. The
disruption of collagen that is seen by the effects of smoking
will have a similar effect (i.e., metastatic emphysema).
The most common defect that results from a denervation phenomenon follows the flank incision that is utilized in a nephrectomy, lumbar sympathectomy, or an anterior approach to the
lumbar interbody fusion for degenerative disc disease. In these
entities, there is no defined fascial edge that is seen with the
more common anterior abdominal wall defects. This is due to
the broad surface of the denervated musculature that has intact
fascia but lacks the reinforcement of healthy muscle tissue.
These are very challenging to repair and such methods are
described elsewhere in this textbook. Mesh materials are necessary for these problems to assure as durable a repair as feasible.
Prosthetic Materials: History
The use of materials for the repairs of hernias can be found
in antiquity. It is believed that Heliodorus used cellulose
from a cotton or flax plant to effect scarification in the
Table 7.2 Natural prosthetic products
Autogenous dermal grafts Whole skin grafts
Dermal collagen homografts Porcine dermal collagen
Autogenous fascial heterografts Lyophilized aortic homografts
Preserved dural homografts Bovine pericardium
Table 7.3 Nonmetallic synthetic products
Fortisan fabric
(cellulose)
Polyvinyl sponge Polypropylene mesh/gelatin film
Polyvinyl cloth Polyester-reinforced silicon sheeting
Nylon mesh Silastic
Carbon fiber Polyester (as a solid sheet)
Silicon-velvet
composite
Polytetrafluoroethylene
Carbon fiber
inguinal area to treat herniation in A.D. 25. The use of silver as a synthetic prosthesis was reported in 1900 [6].
Metallic biomaterials have also included the use of tantalum gauze mesh and stainless steel mesh. None of these
materials gained wide acceptance because of the complications that were associated with their usage. These
included lack of pliability, seroma development, wound
infection, fatigue fractures, herniation through the fracture
sites, abnormal scarification, adhesions, loss of structural
integrity, and allergic reactions. Re-operation in these
patients was particularly challenging.
Natural prostheses were considered as myofascial replacement shortly after the use of silver filigree [7]. Other materials that have been used are listed in Table 7.2.
These materials were used with good results in some
cases but scarcity and cost limited their widespread adoption. Additionally, there were concerns of viral transmission
as one case of Creutzfeldt-Jacobs disease developed in a
patient that had the use of a dural homograft. The development of other synthetic biomaterials that were closer to the
ideal prosthesis hastened the demise of the use of these products in the past. As we now have seen over the last several
years, some of these products have seen resurgence. Updated
methods of processing these products have allowed for
improved safety and efficacy resulting in an expansion of
their use. The use of these biological products is still undergoing careful scrutiny for the most appropriate application of
these expensive materials.
A series of nonmetallic synthetic prosthetic biomaterials
were used as well (Table 7.3). As with the metal materials,
there were significant disadvantages with these products
also. These included infections, sinus tract formation, alteration of the product in vivo, and lack of incorporation into the
native tissues. The use of the carbon fiber in humans has
never been attempted because of concerns of potential carcinogenicity (although it functioned fairly well in the experi-
7 Prostheses and Products for Hernioplasty
111
Table 7.4 Ideal characteristics of synthetic products
No physical modification by tissue
fluids
Does not incite inflammatory or
foreign body reaction
Noncarcinogenic Resistant to mechanical
Can be fabricated to the form
required
Table 7.5 Ideal surgical clinical characteristics of synthetic products
Permanent repair of the abdominal wall (i.e., no recurrences)
In-growth characteristics that result in a normal pattern of tissue
repair and healing
No alteration of the compliance of the abdominal wall musculature
Lack of adhesion predisposition
Cuts easily and without fraying
Inexpensive
Lack of long-term complications such as pain or fistualization
Chemically inert
Does not produce allergy or
hypersensitivity
strains
Sterilizable
mental model). With some of these materials, newer hernia
repair products have used these materials again because of
more modern manufacturing capabilities.
All of these biomaterials were attempting to address the
“ideal characteristics” that were promulgated by Cumberland
and Scales [8, 9]. While it is widely felt that the ideal material has yet to be found, these criteria are the goals that are
sought by the manufacturers (Table 7.4).
While the clinical uses of these prosthetic materials
share these considerations, the operating surgeon does, in
fact, desire slightly different priorities in the use of the
prosthesis within his or her individual patient. Disregarding
the obvious need to be non-carcinogenic, the clinical
characteristics of the “ideal surgical” material are listed in
Table 7.5.
Biologic prostheses are based upon the use of porcine,
bovine, or cadaveric tissues to produce a collagen matrix.
These materials are not truly absorbable as they are
intended to provide a scaffold for the native fibroblasts to
incorporate natural collagen to repair a fascial defect. It
is the goal of these devices to repair the hernia defect
with the tissues of the patient as these will be degraded
and replaced over time.
The synthetic prosthetic materials can be divided into
the absorbable and non-absorbable products. The synthetic
non- absorbable materials are of many types, sizes, and
shapes. The use of these products is commonplace in the
repair of virtually all hernias. There has been an increase
in the number of synthetic absorbable products over the
last several years. More recently there are hybrid products
that include both absorbable and non-absorbable layers.
These attempt to capitalize on the attributes of both of
these technologies.
The materials that are presented below are given in an
arbitrary arrangement and with as accurate information
that could be obtained. An effort was made, however, to
stratify these products in a classification that grouped similar products together. I have attempted to identify all of
the currently available products that are used in most parts
of the world at the time of publication. Some of these
materials have either no published clinical data or scant
information as to the clinical performance characteristics.
Therefore, it is certain that some products and/or details
have been overlooked despite my efforts to present all that
I could identify. Due to the very large variation in the sizes
of the products, little comment regarding the sizes of these
products will be given. The reader is referred to the respective manufacturer for these details. It should also be noted
that not all of these products are available in all countries.
Manufacturers have limited the release of many of them to
only selected areas of the world or have not obtained the
necessary governmental approvals for clinical distribution
at the time of this writing. Finally, it is certain that all of
the available products are not included in this compilation
or that some of those listed are no longer available due to
the lag in this research and actual publication. Many companies are quite small and/or have limited distribution.
Therefore, if any of these that are not included it was not
because of an intended omission but rather a lack of obtainable information.
Absorbable Prosthetic Biomaterials
The general purpose of these is the temporary replacement of
absent tissue (Table 7.6). The strength of these materials and
the lack of permanency make some of them unsuitable for
the permanent repair of any hernia. The newer research has
suggested that this materials might be preferred in some circumstances rather than a true biologic. This may be due to
the fact that biologics require degradation then rebuilding of
the collagen of the patient’s fascia. These materials do not
require the extent of cellular degradation that true biological
Table 7.6 Absorbable products
Bio-A, W. L. Gore & Associates, Elkhart, DE
Bio-A Hernia Plug, W. L. Gore & Associates, Elkhart, DE
Dexon, Medtronic, Minneapolis, MN, USA
Safil Mesh, B. Braun Surgical, Germany
TIGR mesh, Novus Scientific Pte Ltd, Singapore
Phasix mesh, CR Bard, Providence, RI, USA
Phasix mesh Plug and Patch, CR Bard, Warwick, RI, USA
Phasix ST mesh, CR Bard, Providence, RI, USA
Vicryl (knitted) mesh, Ethicon, Inc., Somerville, NJ, USA
Vicryl (woven) mesh, Ethicon, Inc., Somerville, NJ, USA
112
K.A. LeBlanc
materials require and seem to progress to reconstructive
metabolism more rapidly. This is an area of ongoing research.
Clinical usage will be dependent upon the longevity of the
material that is sought by the surgeon.
Bio-A, Phasix, and TIGR meshes represent a somewhat
newer concept in synthetic materials. This field of materials
perhaps represents part of the next phase of mesh development. As will be seen below, combination products have
now been developed with a permanent backbone and the
absorbable materials listed here. The Bio-A product is supplied in flat sheets (Fig. 7.1). It is made of trimethylene car-
bonate and polyglycolic acid. It will maintain approximately
70% of its tensile strength for 21 days. It serves as a scaffold to allow for fibroblastic infiltration and replacement by
the patient’s native collagen. Recent studies have shown
efficacy for complex situations [10]. It can be used in inguinal, incisional, and hiatal hernia repair. The latter is specifically configured for that use. This material is also configured
into the Bio-A Hernia Plug (Fig. 7.2). This configuration
can be used in the groin, umbilical or ventral hernia repair.
Safil Mesh is a warp-knitted polyglycolic acid material
that will retain 50% of its strength at 20 days and is totally
resorbed in 60–90 days (Fig. 7.3). It is used to strengthen the
closure of the abdominal and chest walls. The above photo
also shows the bags into which this material is also shaped
for use in splenic preservation.
Phasix is composed of poly-4-hydroxybutyrate (P4HB).
This is produced from by-products of E. coli metabolism
(Fig. 7.4). It is degraded by hydrolysis and hydrolytic
enzymatic processes. The absorption of the material is
minimal until about 26 weeks post-implantation and is
essentially complete in about 52 weeks. The Phasix has
been configured into a plug similar to the Perfix plug and
patch (Fig. 7.5). Its use is similar to that device except that
Fig. 7.1 Bio-A
Fig. 7.2 Bio-A hernia Plug
Fig. 7.3 Safil mesh
Fig. 7.4 Phasix
7 Prostheses and Products for Hernioplasty
Fig. 7.5 Phasix plug and patch
113
Fig. 7.7 TIGR matrix surgical mesh
of sufficient durability to formally repair a defect. Most frequently these are used to provide a buttress of support for the
temporary closure of an infected incisional wound of the
abdomen or in the patient with intra-abdominal sepsis or
abdominal compartment syndrome. They have also been
used in the treatment of complex or very large hernias that
will be repaired in a staged fashion. In that instance, this
product will be placed as a bridge and the patient will be
returned to the operating room within a few days to perform
the definitive procedure. These represent a less costly alter-
native to biologic materials for this application.
Fig. 7.6 Phasix ST
it is not permanent. The flat mesh is also available with a
barrier coating of carboxymethylcellulose and hyaluronic
acid as Phasix ST (Fig. 7.6). This product is placed in the
intraperitoneal position against the intestine. There are
many investigations that are ongoing to learn the unique
properties of this product.
TIGR Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers, polyglycolic acid and polylactic acid (Fig. 7.7). The Matrix is warp-knitted in a
proprietary way, allowing it to gradually degrade over
time. The strength of the Matrix is comparable to conventional mesh implants for the initial 6–9 months following
implantation. The first fiber (polyglycolic acid) appears to
lose its functional capabilities in 2 weeks while the second
fiber (polylactic acid) maintains its strength for approximately 9 months.
The Vicryl and Dexon meshes are primarily polylactic
acid (Figs. 7.8 and 7.9). The Vicryl is available in a knitted or
woven configuration as noted in the figure. These products
can be affixed onto the fascia directly with sutures but are not
Fig. 7.8 Vicryl knitted (upper) & woven (lower) (Image courtesy of
Ethicon, Inc.)
Fig. 7.9 Dexon mesh (All rights reserved. Used with Permission of
Medtronic)
114
K.A. LeBlanc
Biologic Products
As noted earlier, these products do not represent a new concept in hernia repair. They are marked improvement of the
materials developed earlier in the last century. They are
based upon a harvested collagen matrix that is manufactured
into sheets of tissue-engineered materials that can be used to
repair defects in the abdominal wall. The concept of these
materials is that the biologic material will allow the migration of the patient’s own fibroblasts onto them so that collagen will be deposited to form a “neo-fascia.” For the most
part, these are used in open techniques but there has been
some usage in laparoscopic methods especially in the repair
of hiatal hernias.
There are similarities of all of the biologic products. They
are the most expensive of all prosthetic materials that repair
or replace the abdominal wall fascia. They are all harvested
from an organism that was once alive. The source will dictate
the size of the material and in most cases, the thickness of the
product. The thickness will be variable in nearly all of them.
Some manufacturers have found creative techniques to
increase the size of the materials available. All of the products are processed to eliminate all cellular and nuclear material as well as any prions. Following this, another process can
be applied to crosslink the collagen at the molecular level.
There is only one product that is currently cross-linked as
discussed below. The final stage is the sterilization of the
prosthesis. It is beyond the scope of this chapter to cover all
of these in detail. However, it should be considered, when
using any of these materials, that the processing plays a large
part into the characteristics and the clinical behavior of them
post-implantation.
In general, the biologic products were introduced for
use in contaminated fields such as a synthetic mesh infection. While they can be used in this manner, it is recommended that the wound should not possess gross pus as the
collagenases of some bacteria and inflammatory cells can
degrade these products. These products are sometimes
used in the repair of very complex non-infected hernias as
well. One concern will be that if the patient possesses an
undiagnosed collagen deficiency disorder, the remodeling
of these products will not occur properly, leading to a predictable failure of the repair. It has also been learned over
the last few years that these products perform best if they
have direct contact with some type of vascularized tissue.
Intuitively, if the expectation of these biologic scaffolds to
become infiltrated by fibroblasts and subsequent collagen
deposition, blood supply will deliver these cells more rapidly. Consequently, a higher failure rate will be noted if a
biologic prosthesis is used as a “bridge” between fascial
edges. It is recommended that if a bridge is unavoidable,
then use of the peritoneum of the hernia sac can provide a
source of vascular supply.
Bovine Products
The bovine products are from dermis or pericardium
(Table 7.7). Only the SurgiMend is fetal (dermal) tissue
(Fig. 7.10). As shown in the figure, it is available in four
different sizes. The associated numbers are the thickness
of the four different products in millimeters. SurgiMend-e
is specifically designed for ventral hernia repair
(Fig. 7.11). It is elliptical in shape, perforated and available in 3 mm or 4 mm thicknesses. SurgiMend MP is similar to the former product in that it is available in four
different thicknesses but is also perforated over its entirety
(Fig. 7.12).
Tutomesh and Tutopatch are of the same source (pericardium) and are processed in the same manner (Figs. 7.13
and 7.14). The only difference in these two is that the
Tutomesh is perforated while Tutopatch is not. Veritas is
also pericardium and does not require rehydration
Table 7.7 Bovine biologic prostheses
SurgiMend 1.0,2.0,3.0,4.0, Integra LifeSciences, USA
SurgiMend-e, Integra LifeSciences, USA
SurgiMend MP, Integra LifeSciences, USA
Tutomesh, RTI Biologics, Alachua, FL, USA
Tutopatch, RTI Biologics, Alachua, FL, USA
Veritas, Baxter Healthcare Corporation, Deerfield, IL USA
Fig. 7.10 SurgiMend 1.0–4.0
7 Prostheses and Products for Hernioplasty
Fig. 7.11 SurgiMend-e
115
Fig. 7.13 Tutomesh
Fig. 7.12 SurgiMend MP
(Fig. 7.15). The use of all of these bovine products has generally been limited to the incisional hernia repair. However
there has been increasing application in the repair of hiatal
hernias.
Cadaveric Products
The human cadaveric products have a long history
(Table 7.8). There is significant variability in the amount
of stretch that each of these will undergo either at the time
of implantation or subsequent to the procedure. This
stretch varies from product to product and should be
accounted for at the time of implantation. These products
are not cross-linked and require rehydration. These are
also used in the repair of hiatal hernias. AlloMax Surgical
Graft is 0.8–1.8 mm thick (Fig. 7.16). Cortiva and Cortiva
1 mm are similar materials that are in two different thicknesses. Cortiva is thicker at 1.3 mm (0.8–1.8 mm) and
Fig. 7.14 Tutopatch
Fig. 7.15 Veritas